title: Historical perspectives and the future of adverse reactions associated with haemopoietic stem cells cryopreserved with dimethyl sulfoxide.
abstract: A retrospective review of the published literature identified several hundred adverse reactions (e.g. nausea, chills, cardiac arrhythmias, neurological symptoms and respiratory arrest) associated with the transplantation of stem cells cryopreserved with dimethyl sulfoxide. The occurrences of these are generally accepted as commonplace, as the majority of reactions are transient, whilst a few patients may require clinical treatment. This exploratory study is a collation of the historical data and the expectations for the notification of serious adverse reactions. Outline information is presented on the development of related European Directives, some technical aspects of dimethyl sulfoxide and the sequential stages of preservation and administration.
authors.affiliation: Danish Medicines Agency, Axel Heides Gade 1, 2300, Copenhagen S, Denmark. mic@dkma.dk
authors.forename: Michael A
authors.initials: MA
authors.lastname: Cox
authors.forename: Jens
authors.initials: J
authors.lastname: Kastrup
authors.forename: Mikulas
authors.initials: M
authors.lastname: Hrubiško
mesh_terms: D015925:Cryopreservation / Q000379:methods*; D003451:Cryoprotective Agents / Q000009:adverse effects*; D004121:Dimethyl Sulfoxide / Q000009:adverse effects*; D005060:Europe; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects* / Q000266:history* / Q000295:instrumentation / Q000331:legislation & jurisprudence; D006412:Hematopoietic Stem Cells / Q000166:cytology*; D049673:History, 20th Century; D006801:Humans
chemical_list: D003451:Cryoprotective Agents; D004121:Dimethyl Sulfoxide